Daily Four-Drug Combo Pill Halves Heart Disease Risk: Study

WEDNESDAY May 25, 2011 -- A cheap, once-daily, four-drugs-in-one medication, dubbed a "polypill," appears to cut users' odds for heart disease and stroke by 50 percent, a new international study finds.

The pill combines two blood pressure-lowering medications with aspirin and a cholesterol-lowering statin and is designed to make all these heart-protecting drugs easy to take, researchers say. That, along with its expected cheap cost, might improve compliance with medication regimens, experts suggest.

"We think the role for the polypill is among those at risk of heart disease, in preventing heart attacks and strokes," said lead researcher Dr. Anthony Rodgers, a professor of global health at The George Institute in Sydney, Australia.

The study was funded by public health agencies in Australia, Brazil, New Zealand and the United Kingdom. India-based drug maker Dr. Reddy's Laboratories supplied the pill but did not play a role in funding.

Rodgers stressed that there are still unanswered questions about the pros and cons of using this type of combination pill versus prescribing several pills, where doses and medications are tailored to individual patients. A trial is ongoing to look at that question, he said.

However, tailoring medications in this area is not as important as it once seemed, Rodgers believes. "We realize now the importance of treating the overall risk. And this [pill] is part of that paradigm shift," he said. He noted that the polypill will probably not ever replace the use of individual pills for every patient. "There will always be patients who do better on individually dosed medicines," he added.

The report was published in the May 25 online edition of the journal PLoS One.

The new study included 378 people, typically between the ages of 50 and 70 and assessed to be at a moderately heightened risk for heart disease over the next five years. The participants, who were randomly assigned to receive the polypill or a placebo, came from the United Kingdom, Australia, Brazil, India, New Zealand, the Netherlands and the United States.

Over 12 weeks, people taking the polypill saw an average reduction in their systolic blood pressure (the top number in a reading) of 9.9 mmHg, and what Rodgers called a "significant" 0.8 mmol/L average reduction in their LDL "bad" cholesterol, compared with those receiving placebo. Improvements such as these added up to an estimated halving of cardiovascular risk, the team said.

However, about one in every six people taking the polypill experienced some sort of side effect, the team added. In fact, about one in every 20 users quit the drug because of this, a higher rate than had been seen in prior studies involving the polypill.

Overall, the benefits of the polypill, while significant, were not as large as others have suggested, Rodgers said, and side effects were not as limited as had been thought. Given that finding, Rodgers' group thinks the polypill should be given primarily to those at risk for heart disease or stroke.

Another expert agreed that the study offered up good news and bad.

"There were significant reductions in blood pressure and lipid [blood fat] levels," said Dr. Gregg C. Fonarow, a professor of cardiology at the University of California, Los Angeles. "However, the polypill was less well-tolerated than expected."

Still, he said there's been longstanding interest in developing a single pill with fixed-dose combinations of heart-protective medications, especially for use by people in the developing world who may have limited access to health care, and where low cost is a priority.

"Each of the individual components employed in the polypill are generic medications and available in the U.S. for $40 a year each -- that's $160 for a year supply for all four medications," Fonarow noted. "If integrated into a single pill the expected cost of such a polypill would be even lower," he said.

According to Rodgers, the polypill is expected to cost even less than that -- about $2 a month in poorer countries. And since it is only one daily pill, compliance should be higher compared to when a patient needs to take several pills per day.

According to the report, this polypill will be available in India soon and elsewhere within a few years. Around the world, about 80 percent of all deaths from heart disease, stroke and diabetes happen in low- or middle-income countries, the researchers noted.

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